PharmaAudit Services
Site, TMF and Database Audit
Inspection Preparation
CRO Evaluation
SOP Development
GCP Testing & Training
GCP Training
GCP Knowledge Testing
Free GCP Games
Case Studies
Mock Inspection
TMF Audit
Administration
Home Page
Contact Us
GCP Tests

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.

Test: GMP for IMP 4

Question Number 1:
According to the new EU guideline on the TMF where should the Certificate of Analysis be filed before the study starts?
A
 In the sponsor files only
B
 In the investigator file only
C
 In both the sponsor and the investigator files
D
 In the manufacturing site file only

Question Number 2:
According to the EU GCP directive how long does the Regulatory Authority have to review a GMP licence application for IMP?
A
 30 days
B
 60 days
C
 90 days
D
 There is no time limit

Question Number 3:
Which of the following would NOT be considered a medicinal product under the GCP Directive?
A
 Cell Therapy
B
 A herbal product
C
 A homeopathic product
D
 All of these would be considered medicinal products

Question Number 4:
According to the EU GCP directive how long does the Regulatory Authority have to review a request for a change to an existing GMP licence?
A
 15 days
B
 30 days
C
 60 days
D
 90 days

Question Number 5:
Which of the following provides detailed guidance for manufacture of Medicinal Products in Europe?
A
 Eudralex Vol 1
B
 Eudralex Vol 4
C
 Eudralex Vol 6
D
 Eudralex Vol 10

 
(c) PharmaAudit 2009
All rights reserved
PharmaAudit
Home Page
Contact Us
Related Companies
PharmaSchool Training
PharmaXM Online Testing
Services
Routine Audits
Inspection Preparation